NCT00176410

Statin Therapy in Asymptomatic Aortic Stenosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.

Detailed description

This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	fluvastatin	40mg fluvastatin daily

Timeline

• Start date: 2003-01-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2005-09-15
• Last updated: 2010-01-14

Locations

1 site across 1 country: Germany